UW ICTR has announced the 2021 Pilot Awards; 14 projects were funded totaling $1.02 million that encompass community engaged and health services research, novel methods, and collaborations with our partners at Marshfield Clinic. Christine Sorkness, ICTR Senior Associate Executive Director, comments,

“As always, the ICTR pilot awards team is indebted to the scientific and community reviewers of these applications, especially during these challenging times. We are grateful for the expertise and commitment. Thank you!”

RFAs covered in this announcement include those for Clinical & Community Outcomes Research (CCOR, five awards), Novel Methods (four awards), Stakeholder & Patient Engaged Research (SPER, three awards), and Marshfield Clinic/Marshfield Clinic Research Institute-UW Madison Collaborative Research (two awards).

List of 2021 Pilot Awards

ICTR is funded by the NIH National Center for Advancing Translational Sciences (NCATS), through a Clinical and Translational Science Award most recently renewed in 2017. Pilot awards supporting community-engaged research are also supported via a strategic grant to ICTR from the Wisconsin Partnership Program. The 2021 awards also continue the ICTR record of playing a key role in accelerating basic discovery research, developing novel methods, and promoting partnerships with our partner institution, Marshfield Clinic.

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A proposal from the Forward BIO Institute was one of the four Novel Methods projects selected for funding.

A Systems Approach to Expediting Preclinical Therapeutic Development

William Murphy, PhD, College of Engineering

Collaborators: Christian Capitini, SMPH; Philip Keegan, Cathy Rasmussen, COE;

The translation of cutting-edge technologies from research applications to meaningful therapeutics is inherently complex and requires substantial planning and knowledge that is difficult to obtain in the absence of hands-on experience. Additionally, academics are generally not familiar with many industry best practices, requirements for manufacturing at scale, and/or commercial pressures inherent to commercial therapeutic production. To bridge this knowledge gap, we propose to develop a robust, innovative process that supports navigation of the regulatory landscape for academic innovators working on therapies in early-to-mid-stage development. First, we will leverage our team’s experience and connections within the clinical arena to conduct a survey of industry professionals from three groups based on their familiarity with preclinical development: naïve, familiar, and experts. We will then use this information to construct a process map that outlines the interdependent steps involved in navigating the complex preclinical process, identifying critical points for de-risking therapeutic technology. Finally, this process map will enable our team to disseminate this milestone-driven approach to researchers using an interactive, centralized, online resource, which can be easily updated and disseminated as the field advances. Successful completion of these Aims will result in an effective decision-making process that will be refined in an iterative process for implementation in larger test groups, adapting to the requirements of preclinical development as they expand.

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